54147 Efficacy of Ruxolitinib Cream for Treatment of Atopic Dermatitis in Children Aged 2–<12 Years by Baseline Clinical Characteristics: Subgroup Analysis From a Randomized Phase 3 Study (TRuE-AD3)
Recommended Citation
Armstrong AW, Eichenfield LF, Lee LW, Brar KK, Joyce JC, Forman SB, Soong W, Sofen H, Angel B, Li Q, Stein-Gold L. 54147 Efficacy of Ruxolitinib Cream for Treatment of Atopic Dermatitis in Children Aged 2–<12 Years by Baseline Clinical Characteristics: Subgroup Analysis From a Randomized Phase 3 Study>(TRuE-AD3). J Am Acad Dermatol 2024; 91(3):AB199.
Document Type
Conference Proceeding
Publication Date
9-1-2024
Publication Title
J Am Acad Dermatol
Keywords
ruxolitinib, adolescent, adult, atopic dermatitis, body surface, child, conference abstract, controlled study, cream, dermatitis, drug therapy, Eczema Area and Severity Index, female, human, major clinical study, male, phase 3 clinical trial, preschool child, pruritus, randomized controlled trial, school child, side effect, special situation for pharmacovigilance, therapy
Abstract
Background: Atopic dermatitis (AD), a highly pruritic inflammatory skin disease, typically begins in childhood and affects up to 23% of children globally. Ruxolitinib cream was effective and well tolerated in adults/adolescents (TRuE-AD1/TRuE-AD2 [NCT03745638/NCT03745651]) and children 2–<12 years old (y/o; TRuE-AD3 [NCT04921969]). Here, efficacy by baseline clinical characteristics in children 2–<12 y/o enrolled in TRuE-AD3 is reported. Methods: Patients 2–<12 y/o with AD for ≥3 months, Investigator’s Global Assessment (IGA) score of 2/3, and 3%–20% affected body surface area (BSA) were randomized (2:2:1) to apply twice-daily ruxolitinib cream (0.75%/1.5%) or vehicle for 8 weeks. Results: Patients 2–<12 y/o (N=330) had a median (range) age of 6 (2–11) years; AD duration, 4.8 (0.3–11.3) years; mean (SD) affected BSA was 10.5% (5.40%). At Week 8, 49/134 (36.6%) children applying 0.75% ruxolitinib cream and 74/131 (56.5%) applying 1.5% ruxolitinib cream vs 7/65 (10.8%) applying vehicle achieved IGA treatment success (IGA-TS; score 0/1 with ≥2-grade improvement from baseline); 69/134 (51.5%) and 88/131 (67.2%) vs 10/65 (15.4%) achieved ≥75% improvement in Eczema Area and Severity Index (EASI75), respectively. IGA-TS was observed regardless of baseline AD severity measure. For IGA-TS: IGA score of 2 and 3, 32.3%/48.4% vs 0% and 37.9%/59.0% vs 14.3%, respectively; EASI score ≤7 and >7, 41.7%/58.8% vs 17.2% and 30.6%/55.0% vs 5.6%. Ruxolitinib cream was well tolerated; no serious treatment-emergent adverse events were reported. Conclusions: Ruxolitinib cream is a well-tolerated and effective treatment for AD in children 2–<12 y/o, independent of baseline clinical characteristics.
Volume
91
Issue
3
First Page
AB199
